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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The substance is irritating to skin but not irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to attachment for read across justification
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Remarks:
4h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 15 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Remarks:
4h exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 15 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
3rd animal not required
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks:
not applicable
Remarks on result:
other: not applicable - 3rd animal not required
Irritation parameter:
edema score
Remarks:
4h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 15 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
edema score
Remarks:
4h exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
3rd animal not required
Time point:
other: 3rd animal not required
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: 3rd animal not required
Irritant / corrosive response data:
Positive indication of irritation based on erythema mean score of 2.5 for 2 animals

3 -minute exposure

Well-defined erythema with or without very slight or slight oedema was apparent during the first four days after removal of the dressings. On Day 6 and 8 very slight erythema and exfoliation were evident; exfoliation alone was apparent on Day 15.

The Primary Irritation Index after 3 minute exposure was calculated to be 3.0; the mean score for the assessment 24, 48 and 72 hours after bandage removal reached the EC classification threshold. Accordingly, a 3 minute exposure of T-13 gave rise to a 'moderate irritant' response which would, if seen in two or more animals, warrant labelling with R38 "Irritating to skin" risk phrase.

1 -hour exposure

Very-slight or well-defined erythema with or without very slight oedema was evident throughout the first week after bandage removal; from 24 hours after bandage removal resolving during the second week the reaction was noted to have spread beyond the application site and from Day 6 exfoliation was apparent. Exfoliation alone was evident on Day 15.

The Primary Irritation Index after 1 hour exposure was calculated to be 3.0; the mean score for the assessment 24, 48 and 72 hours after bandage removal reached the EC classification threshold. Accordingly, a l hour exposure of T-13 gave rise to a 'moderate irritant' response which would, if seen in two or more animals, warrant labelling with R38 "Irritating to skin" risk phrase.

Four hour exposure

Well-defined or moderate to severe erythema with or without very slight or slight oedema was apparent throughout the first week after bandage removal; a clear staining on the periphery of the test site was evident during this time. One animal additionally showed blanching of the test site during the first four days of observations, loss of flexibility on Days 6 and 8, sensitivity to touch 24 hours after bandage removal and the reactions spread beyond the application site. Exfoliation was apparent in both animals during the last week of the observation period.

Interpretation of results:
other: Irritating according to CLP classification criteria
Conclusions:
According to CLP classification criteria, irritation Cat 2 applies when erythema or odema scores are >=2.3 - <=4.0 in two out of three animals. In this study a conclusion on classification for irritation could be made with the use of only 2 animals (erythema score 3 in one animal and erythema score 2 in the other animal). On this basis the substance is classified as irritant Cat 2.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to attached read across justification.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation

No abnormal signs or symptoms were observed in any animal throughout the course of the study.

No abnormal signs of pain and distress were evident in three animals immediately after test substance application and at 1, 24, 48 and 72 hours after test substance application.

All animals exhibited normal body weight gains. The mean body weight gain throughout the observation period was 0.11 kg.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance, T-12, was considered to be 'Practically nonirritating' to New Zealand White rabbits eye under the conditions of this study.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation


The skin irritation of T-13 was determined by HLS, 2005, Report No.: IDK 99. The study was conducted in accordance with OECD Guideline 404, EU method B4 and EPA OPPT 870.2500, and was considered reliable.


Eye irritation


The eye irritation of T-13h was determined by Biotoxtech, 2014, Report No.: B14170. The study was conducted in accordance with OECD Guideline 405 and was considered reliable.


Justification for selection of skin irritation / corrosion endpoint:


A single study is available. It is considered to be adequate and reliable.


 


Justification for selection of eye irritation endpoint:


A single study is available. It is considered to be adequate and reliable.


 


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Skin irritation

Category 2: irritant

Erythema >=2.3 -< =4.0, (actual value 3) in one animal out of two. The other animal mean erythema score is 2 which, although not >-2.3 indicates and adverse effect and supports the classification requirement for the first animal. The substance also produces irreversible effects (exfoliation at day 15, other effects during observation period (blanching, loss of flexibility, staining, sensitivity to touch).

Eye irritation

Not classified

Zero scores for all animals for opacity, iritis, redness and oedema at 24, 48 and 72 hrs.